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EC number: 606-883-4 | CAS number: 219921-94-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-09-1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: In compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Principles of Good Labaratory Practice and the "Chernikaliengesetz" of the Federal Republic of Germany.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- EC Number:
- 606-883-4
- Cas Number:
- 219921-94-5
- Molecular formula:
- C16-H26-N2 x C7-H11-N-O5
- IUPAC Name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- Details on test material:
- - Name of test material (as cited in study report): AG-EE 623 Glutaminate
- Purity test date: dating from November 29, 1995
- Lot/batch No.: WB 02
- Expiration date of the lot/batch: guaranteed until November 30, 1996
- Other: location of study: Dr. Karl Thomae GmbH, 88397 Biberach
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino rat Chbb:THOM (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, 88397 Biberach
- Age at study initiation: 48-55 days
- Weight at study initiation: 128,1-224,2 g
- Fasting period before study: 1 day
- Housing: Collective housing in Noryl cages, type IV,
- Diet (e.g. ad libitum): ad libitum after 5h after administration, dry food
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 45%-75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 9/15 hours (7.00 a.m.-4.00 p.m.)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Hydroxyethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 250, 100 and 10 mg/ml
- Amount of vehicle (if gavage): 20 ml/kg - Doses:
- 200, 2000, 5000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The overall appearance and behavior of each animal were observed at least twice a day. Body weight of the animals was determined on the day of administration (day 1), as well as on days 2, 3, 5, 7 and 14 of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD50 (approximate lethal dose)
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5000 mg/kg: 5/6 animals died until 6 hours after treatment.
2000 mg/kg: 5/6 animals died until 1.5 hours after treatment, one animal was found dead at day 3.
200 mg/kg: No animal died after treatment and through the end of the experiment. - Clinical signs:
- other: 5000 mg/kg: Beginning 30 min after administration salivation, ataxia, mucous feces, lateral and abdominal position, tonoclonic convulsions and piloerection were seen in all the animals. Five of six animals died up to 6 hours after treatment. From day 2 un
- Gross pathology:
- 5000 mg/kg:
The died animals showed hemorrhagic edema of the gastric mucosa. Two males and two females had additionally hyperemia of liver, spleen and kidneys. Reduced size of testes and epididymes size as well as perigastric organ adhesions and one node in the gastric area were observed in the surviving rat.
2000 mg/kg
Hemorrhagic gastric edema with hemorrhagic intestinal content as well as hyperemia of liver, spleen and kidneys were found in the initially died animals. The short time surviving animal had hyperemia of liver and lungs
200 mg/kg
No remarkable gross lesions.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral administration of 5000 mg/kg and 2000 mg/kg led to severe toxic reactions followed by death of most animals of these groups. The
animals of the 200 mg/kg treated group showed slight toxic symptoms and survived the 14 days observation period.
Thus the ALD50 of the test item following oral administration in rats is higher than 200 mg/kg and lower than 2000 mg/kg.
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